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Medicrea International Recalls
22 recalls on record · January 8, 2020 to January 21, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 21, 2026Medical DevicesFDA
Medicrea International recalls Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Hazard: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
January 21, 2026Medical DevicesFDA
Medicrea International recalls Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Hazard: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
February 12, 2025Medical DevicesFDA
Medicrea International recalls UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-b
Hazard: Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.
August 30, 2023Medical DevicesFDA
Medicrea International recalls IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B201719
Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
August 30, 2023Medical DevicesFDA
Medicrea International recalls IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B153340
Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
August 30, 2023Medical DevicesFDA
Medicrea International recalls IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B2024020
Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
August 30, 2023Medical DevicesFDA
Medicrea International recalls GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A131
Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
August 30, 2023Medical DevicesFDA
Medicrea International recalls PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B023165
Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
August 30, 2023Medical DevicesFDA
Medicrea International recalls IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B159
Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
August 30, 2023Medical DevicesFDA
Medicrea International recalls IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B2018176
Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
August 30, 2023Medical DevicesFDA
Medicrea International recalls IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B1612451
Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
August 30, 2023Medical DevicesFDA
Medicrea International recalls IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar
Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
August 30, 2023Medical DevicesFDA
Medicrea International recalls IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion devic
Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
August 30, 2023Medical DevicesFDA
Medicrea International recalls IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122
Hazard: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
November 25, 2020Medical DevicesFDA
Medicrea International recalls MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for dege
Hazard: Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-intervention ,
March 18, 2020Medical DevicesFDA
Medicrea International recalls Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580
Hazard: An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.
March 18, 2020Medical DevicesFDA
Medicrea International recalls Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004
Hazard: An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.
February 26, 2020Medical DevicesFDA
Medicrea International recalls Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500
Hazard: Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)
February 19, 2020Medical DevicesFDA
Medicrea International recalls Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
Hazard: Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter
January 29, 2020Medical DevicesFDA
Medicrea International recalls Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140
Hazard: Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded
January 29, 2020Medical DevicesFDA
Medicrea International recalls Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
Hazard: Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded
January 8, 2020Medical DevicesFDA
Medicrea International recalls Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIA
Hazard: It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum area. As a result, a screw that is too long could come into contact with the nerves and cause postoperative pain.